This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation \- All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation * Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. * Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
665
1.2 mg once daily, subcutaneous (under the skin) injection
Tablets, 100 mg daily
Tablets, minimum 1500 mg daily
1.8 mg once daily, subcutaneous (under the skin) injection
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Escondido, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Time frame: Week 0, Week 52
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Time frame: Week 0, Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Time frame: Week 52, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 26
Time frame: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 52
Time frame: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the FAS.
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c \< 7.0% at Week 78. Based on the extension 2 FAS.
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Calculated as the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 26
Time frame: Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 52
Time frame: Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the FAS.
Time frame: Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78
Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =\< 6.5% at Week 78. Based on the extension 2 FAS.
Time frame: Week 0, Week 78
Mean Change From Baseline in Body Weight at Week 26
Calculated as an estimate of the mean change from baseline in body weight at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Body Weight at Week 52
Calculated as an estimate of the mean change from baseline in body weight at Week 52.
Time frame: Week 0, Week 52
Mean Change in Body Weight From Week 52 to Week 78
Mean change in body weight from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.
Time frame: Week 0, Week 52
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78
Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.
Time frame: Week 0, Week 78
Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78
Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Beta-cell Function at Week 26
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 0, Week 26
Mean Change From Baseline in Beta-cell Function at Week 52
Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 0, Week 52
Mean Change in Beta-cell Function From Week 52 to Week 78
Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).
Time frame: Week 52, Week 78
Mean Change From Baseline in Total Cholesterol at Week 26
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Total Cholesterol at Week 52
Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.
Time frame: Week 0, Week 52
Mean Change in Total Cholesterol From Week 52 to Week 78
Mean change in total cholesterol from Week 52 to Week 78
Time frame: Week 52, Week 78
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52
Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78
Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52
Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.
Time frame: Week 0, Week 52
Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78
Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52
Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78
Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Triglycerides (TG) at Week 26
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Triglycerides (TG) at Week 52
Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Triglycerides (TG) From Week 52 to Week 78
Mean change in triglycerides (TG) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52
Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78
Mean change in free fatty acids (FFA) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Apolipoprotein B at Week 26
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Apolipoprotein B at Week 52
Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Apolipoprotein B From Week 52 to Week 78
Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26
Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.
Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.
Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Adiponectin at Week 26.
Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.
Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.
Time frame: Week 0, Week 26
Mean Change From Baseline in Waist to Hip Ratio at Week 26.
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 0, Week 26
Mean Change From Baseline in Waist to Hip Ratio at Week 52
Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 0, Week 52
Mean Change in Waist to Hip Ratio From Week 52 to Week 78
Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.
Time frame: Week 52, Week 78
Mean Change From Baseline in Waist Circumference at Week 26.
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Waist Circumference at Week 52
Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.
Time frame: Week 0, Week 52
Mean Change in Waist Circumference From Week 52 to Week 78
Mean change in Waist Circumference from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26
Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26
Time frame: Week 0, Week 26
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52
Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78
Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52
Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.
Time frame: Week 0, Week 52
Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78
Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Pulse at Week 26
Calculated as an estimate of the mean change from baseline in pulse at Week 26.
Time frame: Week 0, Week 26
Mean Change From Baseline in Pulse at Week 52
Calculated as an estimate of the mean change from baseline in pulse at Week 52.
Time frame: Week 0, Week 52
Mean Change in Pulse From Week 52 to Week 78
Mean change in pulse from Week 52 to Week 78.
Time frame: Week 52, Week 78
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 0, Week 26
Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 0, Week 52
Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78
The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.
Time frame: Week 52, Week 78
Hypoglyceamic Episodes, Weeks 0-26
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Hypoglyceamic Episodes, Weeks 0-52
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-52
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52
Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-52
Hypoglyceamic Episodes, Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-78
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78
Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-78
Hypoglycaamic Episodes, Weeks 52-78
Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Week 52-78
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Novo Nordisk Investigational Site
Northridge, California, United States
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Orange, California, United States
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Poway, California, United States
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